Countering the Problem of Falsified and Substandard Drugs (2013) / Chapter Skim
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2 The Effects of Falsified and Substandard Drugs
2 The Effects of Falsified and Substandard Drugs
Pages 55-84
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From page 55... ...
. The fallout of falsified and substandard medicines includes poisoning, untreated disease, early death, and treatment failure.
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• s chronic diseases increase in low- and middle-income countries, so A will the need for reliable medicines. • ubstandard and falsified medicines encourage drug resistance, S threatening the health of populations today and in the future.
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A random sample of all known medicine shops in three districts of Ghana found the uterotonic drugs oxytocin and ergometrine to be of uniformly poor quality: 89 percent of the samples tested were below British Pharmacopoeia specifications though only 2 percent were expired (Stanton et al., 2012)
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Medications for Chronic Diseases In 2009 a southwest China newspaper reported on a substandard version of the diabetes drug glibenclamide (also called glyburide) found to contain six times the pharmacopeial standard dose (Xiang, 2009)
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The manufacturer sold approximately one million substandard test strips to importers, and from there the strips went through the sup ply chain to reach U.S. and Canadian pharmacies.
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The treatment of pneumonia and other devastating bacterial infections depends on effective antibiotic supply. No research to date has attempted to quantify the proportion of child deaths attributable to falsified and substandard medicines, but Table 2-1 presents the most common causes of child death and links them to verified reports of substandard medicines.
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If antibiotics are some of the oldest and most widely used medicines in the world, antiretrovirals are their opposites: new medicines, prescribed in complicated regimes, to a relatively small segment of the population. An exhaustive WHO survey of antiretroviral drug quality in seven sub-Saharan African countries and a variety of treatment centers found reliable good quality in HIV medications (WHO, 2007)
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These products also encourage drug resistance and thereby threaten population health today and for future generations. This is a particular concern with substandard products where the dose of active ingredient is low and variable and with falsified products diluted by criminals in an effort to pass screening assays.
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In a qualitative study in Orissa, India, doctors, veterinarians, and pharmacists cited poor-quality antibiotics as a cause of drug resistance, but mentioned it only in passing, focusing more on patient and provider behaviors (Sahoo et al., 2010)
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64 MDR-TB among new TB cases (%) 0-2.9 3-5.9 6-11.9 12-17.9 > 18 No data Subnational data only Not applicable FIGURE 2-1 Increasing incidence of multidrug-resistant tuberculosis (MDR-TB)
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Antimalarial Resistance Through a conceptually similar mechanism, selectively allowing the growth of drug-resistant parasites by exposing them to subtherapeutic doses of medicines, falsified and substandard drugs favor survival and spread of resistance to antimalarial medicines. Drug-resistant parasites of particular concern are the malaria parasites Plasmodium falciparum and Plasmodium vivax.
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. So far, artemisinin resistance has been documented only in Southeast Asia, but its persistence and spread could threaten global malaria control programs.
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They also have economic Key Findings • Treatment with substandard and falsified drugs wastes time and money, raising drug costs to patients and the health system. • Drug resistance reduces the effective life of a drug, and society must bear the cost of new drug development.
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Costs to the Health System First, the use of falsified and substandard medicines costs the health care system. Providers do not usually suspect that the drugs they prescribe are of poor quality and will respond to a poor therapeutic response by
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When government or donors supply medicines, they shoulder the added costs of falsified and substandard drugs. Chapter 4 describes the pressure on procurement agencies to fill drug orders for the lowest prices, a false frugality that can cause the wasting of an entire medicines budget on drugs with insufficient active ingredients.
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Drug resistance reduces the effective life of a drug. Already the cheapest, oldest classes of anti-infective drugs are becoming useless.
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They continue working and self-treat with medicines of dubious quality from the gray market. In Brazil, as in many parts of the world, falsified and substandard medicines extract the highest costs from those who can afford the least.
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. During a site visit to Brazil, the IOM delegation heard that, although the Brazilian drugs regulatory authority is strong, the public still doubts the quality of many medicines.
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Fake medicines generate income for criminals, and only the weakest evidence, if any, ties them to their crime. Acute cases of medicine poisoning can elicit public outcry, but more often bad drugs go unnoticed, blending in with lawful business.
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. In many parts of the world, falsified and substandard medicines further erode the already weak political infrastructure that allows them to circulate, part of a vicious cycle of poverty and crime.
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; zinc sulfate Campylobacter jejuni Oral rehydration solution (ORS) ; zinc sulfate Erythromycin Yes a,f,g Escherichia coli Oral rehydration solution (ORS)
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76 TABLE 2–1 Continued Known Falsified or Substandard or Common Pathogen Essential Medicine Both? Malaria Plasmodium vivax/ovale/ Amodiaquine Yes i,j falciparum/malariae Artemether Yes i,k,l Artesunate Yes k,l,m Plasmodium vivax/ovale/ Doxycycline Yes a,h falciparum/malariae Mefloquine Yes k,n Sulfadoxine/pyrimethamine Yes l,j,o Quinine Yes j,k,o Artesunate + amodiaquine Yes l Artemether + lumefantrine Yes l Plasmodium vivax Chloroquine Yes f,k,p Primaquine Yes q,r Plasmodium ovale Primaquine
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Lancet 357:1933-1936. survey of the proportion of poor quality oral artesunate sold at medicine outlets d Food and Drug Board of Ghana.
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Journal of Infectious Diseases 201(9)
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2006. FDA updates its nationwide alert on coun terfeit One Touch blood glucose test strips.
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2009. Epidemic of plasmodium falciparum malaria involving substandard antimalarial drugs, Pakistan, 2003.
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2009. A stratified random sur vey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR -- implications for therapeutic failure and drug resistance.
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2009. Hyperparasitaemia and low dosing are an important source of anti-malarial drug resistance.
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2012d. Malaria drug resistance.
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